A Field Study for the Evaluation of AIGIV Clinical Benefit and Safety in the Treatment of Patients With Inhalational Anthrax in a Broad Exposure Event Scenario
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Assessment of AIGIV clinical benefit by overall mortality rate
研究概览
简要总结
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from inhalational anthrax patients treated with AIGIV.
详细描述
This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to patients as part of their medical care after inhalational exposure to Bacillus anthracis. Study information (i.e. data on safety and clinical benefit evaluation of AIGIV up to Day 30 following administration) and patient samples (for assessment of AIGIV pharmacokinetics and anthrax toxin levels) will be collected (up to Day 7 following AIGIV administration) prospectively to the extent possible; however, due to logistical complexities that will likely occur during a mass anthrax exposure event, most data for this study will be collected retrospectively (including scavenged patient samples for assessment of serum AIGIV concentration and anthrax toxin levels). Therefore, both prospective and retrospective data collection are allowed in this study to maximize the amount of information obtained from inhalational anthrax patients who have been administered AIGIV.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
- •Treatment with AIGIV.
- •Informed consent/assent (as applicable).
排除标准
- •There are no exclusion criteria for subjects enrolling in this study.
研究组 & 干预措施
AIGIV
Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.
干预措施: AIGIV (Drug)
结局指标
主要结局
Assessment of AIGIV clinical benefit by overall mortality rate
时间窗: Up to Day 30
Mortality rate (incidence of death) in patients with confirmed diagnosis of inhalational anthrax treated with AIGIV
次要结局
- Assessment of AIGIV clinical benefit by time from symptom onset to death(Up to Day 30)
- Assessment of AIGIV clinical benefit by mortality rate at Day 7 and Day 30(Up to Day 30)
- Assessment of AIGIV safety by incidence of serious adverse drug reactions and serious suspected adverse drug reactions(Up to Day 30)
- Mortality rate stratified by number of AIGIV doses administered(Up to Day 30)